drugset / Trial / NCT01111825

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

NCT01111825

Phase 1/2 Completed 99 enrolled Puma Biotechnology, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.

Timeline

Start
2010-04
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 240 mg Oral
Subject Temsirolimus Small molecule 8 mg Intravenous
Subject Temsirolimus Small molecule 15 mg Intravenous

Indications